Evaluation and revision of the MDR and IVDR
Products
Product safety legislation
One of the cornerstones of the European Union is its Single Market in which goods and services can be traded freely. A central prerequisite for this is uniform product requirements. A product must be marketed equally in France, Poland or Germany. Based on this understanding, product requirements are harmonized and developed further within the EU in a continuous process. Particularly technical specifications must always be entirely up to date and take fundamental trends such as digitalisation and climate protection into account.
Besides setting uniform product requirements, product regulation should also ensure that only products that comply with European legislation are placed on the market within the EU. Manufacturers, retailers and importers confirm their compliance by affixing a CE marking on their products. In most cases, the legislation only requires manufacturers to assess products themselves (a manufacturer’s self-declaration). External assessment by independent bodies is mandatory for particularly high-risk products such as vehicles and certain medical devices (“risk-based approach”).
The TÜV Association is committed to ensuring that products are assessed independently according to their risk potential. Those products that may pose a risk to life, health and physical integrity or to privacy and data protection must be subject to a mandatory assessment by independent conformity assessment bodies.
This “preventive approach” allows testing products before they are even placed on the market thereby reducing the burden on national market surveillance authorities.
A safety network for Europe
The TÜV organisations and their association aim to establish a preventive safety net specifically for high-risk products as an integral component of the European economic and value system. Technical safety and digital security ensure quality of life and are therefore indispensable for a modern society.
Our topics in the area of product safety legislation
News and positions
Your contact
Dr Ingo Steinke
Head of Accreditation, Standardisation and Climate Protection